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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048557
Receipt No. R000055319
Scientific Title Japan Nurses' Health Study: The Next Generation (JNHS-II)
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/02

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Basic information
Public title Japan Nurses' Health Study: The Next Generation (JNHS-II)
Acronym JNHS-II
Scientific Title Japan Nurses' Health Study: The Next Generation (JNHS-II)
Scientific Title:Acronym JNHS-II
Region
Japan

Condition
Condition Women's health
Classification by specialty
Medicine in general Surgery in general Obsterics and gynecology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between the occurrence of various diseases peculiar to women and that of changes in lifestyle habits, health care habits, and reproductive events.
Basic objectives2 Others
Basic objectives -Others The purpose of the 1st follow-up period (10 years) is obtaining knowledge about fertility preservation, and investigate the affect for long-term use of OC / LEP .
We will investigate the relationship about occurence of various diseases and the changes of lifestyle habits, helath care habits, and reproductive events, over the 2nd follow-up period and more.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the 1st follow-up period:
infertility

the 2nd follow-up period:
menopausal symptoms, cancer, cardiovascular disease and osteoporosis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
22 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria Registered nurses, midwife, or public health nurse
Key exclusion criteria Women aged more than 50 yeas old
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Kazue
Middle name
Last name Nagai
Organization Gunma University
Division name Center for Mathematics and Data Science
Zip code 371-8514
Address 3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan
TEL 027-220-8974
Email kazue-nagai@gunma-u.ac.jp

Public contact
Name of contact person
1st name Kazue
Middle name
Last name Nagai
Organization Gunma University
Division name Center for Mathematics and Data Science
Zip code 371-8514
Address 3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan
TEL 027-220-8974
Homepage URL
Email jnhs.jimu@gmail.com

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma University
Address 3-39-22 Showa-machi, Maebashi, Gunma, 371-8511 Japan
Tel 027-220-8763
Email ciru_hitotaisho-irb@ml.gunma-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2022 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2034 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Baseline survey: self reported questionnaire
Follow-up survey: bieneal survey (self reported or online survey)
We will send participants an annual newsletter including articles about the new information on women's health from epidemiologic / medical papers of scientific journals.

Management information
Registered date
2022 Year 08 Month 02 Day
Last modified on
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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